Venous InsufficiencyNCT07823088
Open Label Safety Investigation of Solutio™ Tumescent Catheter
A study testing Administration of local anesthesia in people with Venous Insufficiency, run by MedVasc AB at 2 sites in Sweden.
Trial summary
The goal of this clinical investigation is to evaluate safety of the Solutio™ catheter when administering tumescent anesthesia before treatment with endothermal ablation in adults above the age of 18, who suffer from unilateral insufficiency of the great saphenous vein (GSV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Administration of local anesthesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSweden
- Study dates
- 28 Sep 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female >18 years old.
- Subject diagnosed with venous insufficiency in the Great Saphenous Vein from the groin to the proximal 1/3 of the lower leg and with a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 2 or higher.
- Subject is scheduled for an EVLA or RFA procedure for a unilateral insufficiency of the GSV.
- Subject accepts to be treated with endothermal ablation as a standalone method.
- Subject accepts to be treated without any sedation.
- Subject is willing and able to provide written informed consent.
Who cannot join
- Considered as being of high risk due to comorbidity in the opinion of the investigator.
- Subject with known and confirmed coagulation defects.
- Subject on anticoagulant treatment.
- Subject who simultaneously needs to be treated with other supplemental techniques such as e.g., foam sclerotherapy, ligation, and phlebectomy.
- Subject with GSV insufficiency in the distal 2/3 of the lower leg.
- Subject, who demands full sedation, or general anesthesia.
- Subject with known allergy to any of the tumescent and/or anesthetizing agents that will be used (per local standard practice) during the endothermal ablation procedure.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites
Hallands sjukhus
Halmstad, 301 85
Karin Ludwigs, MD, +46 (0)35 14 77 53, Karin.Ludwigs@regionhalland.se
Scandinavian Venous Centre
Malmö, 21135
Karin Ludwigs, MD, +46707382447, karin.ludwigs@svcgoteborg.se
About this study
Official title: A Prospective, Open Label Investigation of Safety of the Solutio™ Tumescent Catheter for Endothermal Ablation of Varicose Veins
The goal of this clinical investigation is to evaluate safety of the Solutio™ catheter when administering tumescent anesthesia before treatment with endothermal ablation in adults above the age of 18, who suffer from unilateral insufficiency of the great saphenous vein (GSV).
Main question(s) to answer is:
Read more
Safety evaluated through reported Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs).
Incidence of Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE), and device deficiency (DD) throughout the investigation.
All investigation participants will:
- Undergo screening, including medical history, physical examination, and vein mapping with Doppler ultrasound.
- Have their Great Saphenous Vein (GSV) treated using Seldinger technique under ultrasound guidance.
- Receive tumescent anesthesia injected from inside the vein into the perivascular tissue at selected sites along the vein, using the investigational Solutio™ catheter under ultrasound guidance.
- Undergo endothermal ablation, Endovenous Laser Ablation (EVLA), or Radiofrequency Ablation (RFA).
- Be followed up for 28 days through scheduled phone calls (Day 1, Day 14 ±2) and clinic visits (Day 7 ±1, Day 28 ±2) to assess adverse events, pain, patient comfort, and undergo physical/clinical examinations and ultrasound examinations of the treated area.
- Conditions
- Venous Insufficiency
- Being tested
- Administration of local anesthesia
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of local anesthesiaDevice
The Solutio™ catheter presents a technique that allows for tumescent anesthesia injections to be administered at selected sites along the vein, from inside the vein to the surrounding tissue.
The purpose of the Solutio™ catheter is to prevent the pain associated with multiple injections, through sensitive skin layers along the inner side of the leg, administered prior to ablation.
| Study group | Role | What they receive |
|---|---|---|
| Solutio™ catheter used to administrate tumescence during endothermal ablation of varicose veins | Experimental | Administration of tumescence from inside the vein to the surrounding tissue, via Solutio™ catheter during endothermal ablation of varicose veins. Receives: Device: Administration of local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety related to the procedure using the Solutio™ catheter.
Safety evaluated by recording the number and type of adverse device effects (ADEs) and serious adverse device effects (SADEs) related to the procedure using the Solutio™ catheter.
Measured: 28 days
Secondary outcomes (3)
Patient experience of pain
The patient will rate their experience of pain at follow up visits at the clinic and via phone contacts. A Visual Analogue Scale (VAS) measures pain intensity. The scale consists of a 100 mm line, with two end points representing 0 = "no pain" and 100 = "worst pain imaginable". The patient will be asked to make a mark across the line according to the maximum experienced pain to indicate their pain at given timepoints. At phone contacts the patient is asked a standard question to rate their pain with a number from 0 to 10, a Numeric Rating Scale (NRS), where 0 = "no pain" and 10 = "worst pain imaginable"
Measured: 28 days
Physician feedback
After the end of the procedure, the physician is asked to provide their feedback, assessment about 10 different aspects during the procedure. They will answer with a 4-grade scale (1 is excellent, 2 is good, 3 is fair, 4 is impossible /inadequate). Acceptable score is ≤3 for each question.
Measured: 1 day
Patient experience of pain
At phone contacts the patient is asked a standardized question to rate their pain with a number from 0 to 10, a Numeric Rating Scale (NRS), where 0 = "no pain" and 10 = "worst pain imaginable".
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start28 Sep 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Safety study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedVasc AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Akesson, MD, Study director, MedVasc AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823088
- Sponsor's protocol ID
- CSDPR901
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label Investigation of Safety of the Solutio™ Tumescent Catheter for Endothermal Ablation of Varicose Veins
- ClinicalTrials.gov ID
- NCT07823088
- Acronym / sponsor ID
- CSDPR901
- Conditions
- Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MedVasc ABIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical investigation is to evaluate safety of the Solutio™ catheter when administering tumescent anesthesia before treatment with endothermal ablation in adults above the age of 18, who suffer from unilateral insufficiency of the great saphenous vein (GSV).
Main question(s) to answer is:
Safety evaluated through reported Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs).
Incidence of Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE), and device deficiency (DD) throughout the investigation.
All investigation participants will:
- Undergo screening, including medical history, physical examination, and vein mapping with Doppler ultrasound.
- Have their Great Saphenous Vein (GSV) treated using Seldinger technique under ultrasound guidance.
- Receive tumescent anesthesia injected from inside the vein into the perivascular tissue at selected sites along the vein, using the investigational Solutio™ catheter under ultrasound guidance.
- Undergo endothermal ablation, Endovenous Laser Ablation (EVLA), or Radiofrequency Ablation (RFA).
- Be followed up for 28 days through scheduled phone calls (Day 1, Day 14 ±2) and clinic visits (Day 7 ±1, Day 28 ±2) to assess adverse events, pain, patient comfort, and undergo physical/clinical examinations and ultrasound examinations of the treated area.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Safety study
| Arm | Type | Receives |
|---|---|---|
| Solutio™ catheter used to administrate tumescence during endothermal ablation of varicose veins | Experimental | Device: Administration of local anesthesiaAdministration of tumescence from inside the vein to the surrounding tissue, via Solutio™ catheter during endothermal ablation of varicose veins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female >18 years old.
- Subject diagnosed with venous insufficiency in the Great Saphenous Vein from the groin to the proximal 1/3 of the lower leg and with a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 2 or higher.
- Subject is scheduled for an EVLA or RFA procedure for a unilateral insufficiency of the GSV.
- Subject accepts to be treated with endothermal ablation as a standalone method.
- Subject accepts to be treated without any sedation.
Key exclusion criteria (7 listed)
- Considered as being of high risk due to comorbidity in the opinion of the investigator.
- Subject with known and confirmed coagulation defects.
- Subject on anticoagulant treatment.
- Subject who simultaneously needs to be treated with other supplemental techniques such as e.g., foam sclerotherapy, ligation, and phlebectomy.
- Subject with GSV insufficiency in the distal 2/3 of the lower leg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of local anesthesiaThe Solutio™ catheter presents a technique that allows for tumescent anesthesia injections to be administered at selected sites along the vein, from inside the vein to the surrounding tissue. The purpose of the Solutio™ catheter is to prevent the pain associated with multiple injections, through sensitive skin layers along the inner side of the leg, administered prior to ablation. | Device | Solutio™ catheter used to administrate tumescence during endothermal ablation of varicose veins |
Primary outcome
Safety related to the procedure using the Solutio™ catheter.
Time frame: 28 days
Safety evaluated by recording the number and type of adverse device effects (ADEs) and serious adverse device effects (SADEs) related to the procedure using the Solutio™ catheter.
3 secondary outcomes
Patient experience of pain
Time frame: 28 days
Physician feedback
Time frame: 1 day
Patient experience of pain
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Akesson, MD study director
MedVasc AB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of local anesthesia in people with Venous Insufficiency, run by MedVasc AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingegerd W Dalfelt, SRN, BSc. (+46708433348, ingegerd.dalfelt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety related to the procedure using the Solutio™ catheter. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.